The Scientist, Global LTS Microbiology is primarily responsible for supporting the microbiological testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has complete understanding/proficiency and takes supporting role in conducting all types of microbiological/biological analyses (including the most complex analyses) using all equipment. This position will have a support role supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives and is considered a knowledgeable resource for these areas. Write and review SOPs, test methods, validation protocols and reports. The Scientist is responsible for planning, designing, and execution of LTS activities, and assisting technical project teams of analysts and senior analysts. Key responsibilities include developing and validating analytical methods (Sterility test, BET, MLT, AET, Admixture study & other Microbiological analysis) for Finished Product and Raw Material release and stability testing; troubleshooting and improving existing methods; preparing and reviewing method validation protocols, reports, and analytical test methods; performing testing to support process and formulation development; reviewing and approving laboratory test data and documentation; evaluating drug substance supplier’s technical documents; using laboratory software; evaluating new technologies; providing general laboratory support; troubleshooting instrumentation; elevating questionable sample results and participating in root cause investigations; writing and reviewing SOPs and laboratory investigations; providing training on microbiological/biological techniques; maintaining compliance with regulatory and company requirements including cGMP/cGLP; following EH&S procedures to ensure safety. Qualifications include a Bachelor’s degree in Microbiology, Biotechnology, Biochemistry or related field with 6 years’ relevant experience or Master’s with 4 years or PhD preferred; strong knowledge of laboratory microbiology and microbiological instruments; proficiency with various laboratory techniques and instruments; knowledge of FDA, ICH, SOP, cGMP, GLP, DEA regulations; strong analytical, communication, organizational skills; ability to coach staff; physical ability to work in regulated pharma lab environment with PPE. The role supports one Par business at a single site.
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